Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples [ Designated as safety issue: No ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast

Official Title ICMJE

A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast

Brief Summary

RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This clinical trial is studying how well vorinostat works in treating women with ductal carcinoma in situ of the breast.

Detailed Description

OBJECTIVES:

To evaluate the in vivo molecular and biological effects of vorinostat by analyzing changes in proliferation and apoptosis, histone acetylation, and HDAC protein expression in women with ductal carcinoma in situ of the breast.

OUTLINE: Patients receive oral vorinostat twice a day for 3 days in the absence of unacceptable toxicity. Patients then undergo lumpectomy or mastectomy 2 hours after the last dose of vorinostat.

Blood and tissue samples are collected at baseline and during surgery for biomarker laboratory studies. Samples are analyzed by immunohistochemistry for Ki-67, HDAC1 and HDAC6 protein expression, and histone H4 and α-tubulin acetylation.

After completion of study therapy, patients are followed for 1 month and then every 6 months for 5 years.

Fertile patients must use 2 effective barrier methods of contraception

No known psychiatric or substance abuse disorder that would preclude cooperation with the study requirements

No active hepatitis A, B, or C infection

No active HIV infection

No other active infection

No other malignancy within the past 5 years

No condition that would interfere with the absorption or intake of vorinostat

No history or current evidence of any condition or laboratory abnormality that would confound study results, interfere with the patient's participation in the full duration of the study, or that would not be in the best interest of the patient to participate

PRIOR CONCURRENT THERAPY:

More than 2 weeks since prior IV antibiotics, antivirals, or antifungals

No prior gastrointestinal surgery or other procedure that would interfere with the absorption or intake of vorinostat

No prior or concurrent therapy with any other HDAC inhibitor, including valproic acid